Abstract
BackgroundSevere hypoglycaemia (SH) is one of the most feared complications of type 1 diabetes (T1DM) with a reported prevalence of nearly 40%. In randomized trials of Multiple Daily Injections (MDI) and Continuous Subcutaneous Insulin Infusion (CSII) therapy there is a possible benefit of CSII in reducing SH. However few trials have used basal insulin analogues as the basal insulin in the MDI group and individuals with established SH have often been excluded from prospective studies. In published studies investigating the effect of Real Time Continuous Glucose Monitoring (RT-CGM) benefit in terms of reduced SH has not yet been demonstrated. The primary objective of this study is to elucidate whether in people with T1DM complicated by impaired awareness of hypoglycaemia (IAH), rigorous prevention of biochemical hypoglycaemia using optimized existing self-management technology and educational support will restore awareness and reduce risk of recurrent SH.Methods/designThis is a multicentre prospective RCT comparing hypoglycaemia avoidance with optimized MDI and CSII with or without RT-CGM in a 2×2 factorial design in people with type 1 diabetes who have IAH. The primary outcome measure for this study is the difference in IAH (Gold score) at 24 weeks. Secondary outcomes include biomedical measures such as HbA1c, SH incidence, blinded CGM analysis, self monitored blood glucose (SMBG) and response to hypoglycaemia in gold standard clamp studies. Psychosocial measures including well-being and quality of life will also be assessed using several validated and novel measures. Analysis will be on an intention-to-treat basis.DiscussionMost existing RCTs using this study’s interventions have been powered for change in HbA1c rather than IAH or SH. This trial will demonstrate whether IAH can be reversed and SH prevented in people with T1DM in even those at highest risk by using optimized conventional management and existing technology.Trial RegistrationISRCTN52164803 Eudract No: 2009-015396-27
Highlights
Introduction of twice daily glargineParticipants randomised to Multiple Daily Injections (MDI) already on twice daily glargine will continue on this from the outset of the RCT
Most existing RCTs using this study’s interventions have been powered for change in HbA1c rather than impaired awareness of hypoglycaemia (IAH) or Severe hypoglycaemia (SH). This trial will demonstrate whether IAH can be reversed and SH prevented in people with Type 1 diabetes mellitus (T1DM) in even those at highest risk by using optimized conventional management and existing technology
Over recent years, it has become increasingly clear that SH is the major factor limiting the overall level of glucose control achievable in those with established T1DM
Summary
The addition of a second daily glargine dose will be considered for all participants in the MDI group. This can be initiated between study visits if necessary, e.g. after telephone advice. Severe hypoglycaemia (SH) is one of the most feared complications of type 1 diabetes (T1DM) with a reported prevalence of nearly 40%. In randomized trials of Multiple Daily Injections (MDI) and Continuous Subcutaneous Insulin Infusion (CSII) therapy there is a possible benefit of CSII in reducing SH. Tight glycaemic control in the DCCT attained by MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) was associated with a three-fold increase in SH [2]
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